This course will give you an overview of the European regulatory system to provide you with the tools you need to develop a successful regulatory strategy. You will be given information about the different routes for obtaining a license for the European market, including centralized or decentralized procedures; mutual recognition procedures; national procedures; and the specific procedures for orphan drugs, pediatrics, advanced therapies, and combination products. The course will cover the different steps and time lines for each procedure, the clockstops, the compiling of questions, and other key topics.

You’ll also receive a brief introduction to the unique set up of the European regulatory environment, including the different responsibilities of the European Commission, the member states, the European Medicines Agency (EMA), the National Competent Authorities (NCAs), and the Heads of Medicines Agencies (HMA).

Other key topics covered during the course include:
• The European pharmacovigilance legislation, which introduced major changes to licensing procedures when it came into force in July 2012
• Procedures for obtaining scientific advice on a European level and/or via a National Competent Authority (NCA)
• Setup of a dossier – the format, content and required annexes, whether it will be uploaded electronically, paper based, or submitted via other media

Please note: the language of this training course will be English only, but Japanese speaking will be welcomed during group discussions.